Job Details

  • Title: Vault RT Support Specialist
  • Code: RCI-03046
  • Location: Bridgewater New Jersey (NJ) 08807
  • Posted Date: 09/28/2020
  • Duration: 6 Months
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  Job Description

Transforming into digital technology for data management to bring our regulatory compliance into a higher standard of data use and protection, Global Regulatory Affairs CMC & Devices is being integrated in Veeva Vault, a part of regulatory management system.

Reg CMC group as a key stakeholder within GRA CMC&D organization contributes to pipeline success by ensuring regulatory approval for variations / supplements for marketed products. Vault allows accurate Registration Tracking (RT) for all regulatory events including initial submission, amendments, Health Authority query response, approval and life cycle management.

With ever increasing demands for an accurate regulatory database, we have created a new consultant position within GRA CMC&D function to support Vault RT.

As our Vault RT Support Specialist, you will represent Regulatory CMC managers to ensure the proper entry of CMC registration information, maintenance of up-to-date submission records, management of life cycle CMC registration in Vault in alignment with process. Be responsible for managing registration tracking for all CMC submission and Health Authority correspondences related to CMC in Veeva Vault. Interaction with Regulatory CMC managers and GRA Operations in support of Reg CMC business activities.

Required:

  • Manage Vault Registration Tracking for regulatory CMC submission for Global marketed products.
  • Represent RA CMC managers to ensure the proper entry of CMC information in alignment with process.
  • Plan, manage and track status of regulatory CMC submissions (variations /supplements), regulatory impact for variations, publishing requests with creation of core packages and related administrative activities, including information and data entry and uploading submission documentation.
  • Maintain up-to-date CMC registration tracking including updates to registered information and report on approval status and Health Authority correspondences.
  • Manage CMC registration tracking activities including creation, initiation of workflow, closing and archiving in Vault.
  • Communicate effectively with RA CMC managers.
  • Years of Experience: 3 - 6 Years.